Capsulitis of the Shoulder MedDRA version: 9.1 Level: LLT Classification code 10001286 Term: Adhesive capsulitis of shoulder
Conditions
Interventions
Trade Name: Kenalog Intra-articular
Product Name: Kenalog Intra-articular
Pharmaceutical Form: Injection*
Pharmaceutical form of the placebo: Injection*
Route of administration of the placebo: Intraar
Sponsors
South Eastern Health and Social Care Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Adult subjects (>= 18 years) with unilateral shoulder pain of more than 4 weeks duration and a SPADI score of >= 30 as this represents significant disability. Shoulder pain is defined as pain in the shoulder region, including the upper arm, elicited by shoulder movement. “Capsulitis” is defined by finding of limitation of passive range of movement of greater than 25% in both external rotation and abduction as compared with the contra-lateral shoulder with relatively more restriction in external rotation than abduction and internal rotation. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Physiotherapy or injection treatment for current shoulder pain in previous 3 months • inability to give informed consent • blood coagulation disorders • bilateral shoulder pain • abnormal shoulder X-ray defined as significant glenohumeral or subacromial joint space narrowing suggesting OA of glenohumeral joint or complete RC rupture, • evidence of rotator cuff tear, tested by external rotation lag sign, drop sign, internal rotation lag sign and static muscle resistance in external rotation, internal rotation and abduction, • history of significant trauma to the shoulder, • inflammatory joint disease, • history of cerebrovascular accident, • allergy or contraindication to Triamcinolone/contraindication to injection. • evidence of referred pain from cervical spine disease. • pregnancy or breast feeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine if repeated injections are more effective than a single injection in the treatment of shoulder “capsulitis”. ;Secondary Objective: ;Primary end point(s): Shoulder Pain and Disability Index (SPADI) has been shown to be a reliable and valid outcome measure. The SPADI at 26 weeks will be considered the primary end point. | — |
Countries
United Kingdom
Outcome results
None listed